Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
9 recalls
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Class II Ongoing
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3
Reason: Failed dissolution specifications.
Lots, distribution and details
- Lots / codes
- Lot# TY9495, Exp Date: 05/2027.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- September 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0877-2026
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Class II Ongoing
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Lots, distribution and details
- Lots / codes
- Lot # TY9494, Exp Date: 05/31/2027.
- Distribution
- US Nationwide.
- Quantity
- 6,972 bottles
- Recall started
- August 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0804-2026
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Class II Terminated
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad…
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Lots / codes
- Lot # a) GS036488, GS037091, GS037701, Exp. 08/31/2024; b) GS037090, GS037702, Exp. 08/31/2024; c) GS036677, GS037117, GS037699, Exp. 08/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 5626 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0130-2024
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Class II Terminated
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorpor…
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Lots / codes
- Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
- Distribution
- Nationwide in the USA
- Quantity
- 2502 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0129-2024
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Class II Terminated
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad…
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
- Lots / codes
- Lot # a) Lot GS041383, GS042141, Exp. 08/31/2024; b) Lot GS040841, Lot GS041384, Lot GS042039, Exp. 08/31/2024; c) Lot GS040910, Lot GS041621, Lot GS042237, Exp. 08/31/2024;
- Distribution
- Nationwide in the USA
- Quantity
- 1941 bottles
- Recall started
- November 10, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0128-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Lots / codes
- Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 4,074
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0122-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario,…
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
- Lots / codes
- Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 25,776
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0121-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apo…
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
- Lots / codes
- Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 48,623
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0120-2024
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Class II Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontar…
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Lots, distribution and details
- Product
- Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
- Lots / codes
- Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024
- Distribution
- Nationwide
- Quantity
- 34,392
- Recall started
- November 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0119-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.